Healthcare Industry News:  hemodialysis 

Devices Interventional FDA

 News Release - June 11, 2007

Gore AVIATOR Study Receives Conditional Approval from FDA

FLAGSTAFF, Ariz.--(HSMN NewsFeed)--Conditional approval to proceed with the AVIATOR (Angioplasty vs. GORE VIABAHNŽ Endoprosthesis Treatment Of GRaft Stenosis) Study was announced today by W. L. Gore & Associates (Gore). The AVIATOR Study is a randomized, multi-center clinical trial intended to establish efficacy and safety of the GORE VIABAHNŽ Endoprosthesis with PROPATEN Bioactive Surface to revise arterio-venous grafts at the venous anastomosis in hemodialysis patients. The study will randomize patients to the GORE VIABAHNŽ Endoprosthesis and to percutaneous transluminal angioplasty (PTA).

Tom Vesely, MD, Medical Director on the AVIATOR Study and an Interventional Radiologist at Vascular Access Center of Frontenac Grove, MO, states, "The study is designed to demonstrate the clinical benefit of using a stent-graft for AV graft revisions, rather than PTA alone." Vesely continues, "With a focus on target-lesion primary patency, the study is designed to show an increased amount of time between interventions in dialysis access grafts."

The GORE VIABAHNŽ Endoprosthesis devices used in the AVIATOR study will feature the proprietary end-point covalent bonding of heparin, similar to the recently launched GORE PROPATEN Vascular Graft used in AV access. "We are excited to include this latest advance in the GORE VIABAHNŽ Product line, the GORE VIABAHNŽ Endoprosthesis with PROPATEN Bioactive Surface, in the study," states Melissa Brookshier, M.S., Gore Product Specialist. "We anticipate study enrollment to begin in early Fall, 2007."

The GORE VIABAHNŽ Endoprosthesis with PROPATEN Bioactive Surface is constructed with a durable, biocompatible, expanded polytetrafluoroethylene (ePTFE) liner with a proprietary covalently bonded heparin surface, reinforced with an external nitinol stent structure. Worldwide, more than 70,000 GORE VIABAHNŽ Endoprostheses have been implanted.

ABOUT W. L. GORE & ASSOCIATES

The Gore Medical Products Division has provided creative therapeutic solutions to complex medical problems for three decades. During that time, more than 23 million innovative Gore Medical Devices have been implanted, saving and improving the quality of lives worldwide. The extensive Gore Medical family of products includes vascular grafts, endovascular and interventional devices, surgical meshes for hernia repair and sutures for use in vascular, cardiac and general surgery. Gore was recently named the tenth best company to work for by Fortune magazine.

Products listed may not be available in all markets pending regulatory clearance.

GORE, PROPATEN and VIABAHNŽ are trademarks of W. L. Gore & Associates.


Source: W. L. Gore

Issuer of this News Release is solely responsible for its content.
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